Benign Prostatic HyperplasiaPhase 4NCT05494567
Efficacy of Tadalafil/Solifenacin VS Tamsulosin/Solifenacin Combination Therapy for BPH/OAB
A Phase 4 study testing Tadalafil 5mg, Tamsulosin Hcl 0.4 mg and solifenacin 10 mg in people with Benign Prostatic Hyperplasia and Overactive Bladder, run by Mansoura University at 1 site in Egypt.
Trial summary
The investigators will compare the efficacy and safety of tadalafil/solifenacin combination therapy versus tamsulosin/solifenacin combination therapy for the treatment of BPH/OAB in a randomized controlled trial (RCT). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Overactive Bladder
- What is being tested?
- Tadalafil 5mg, Tamsulosin Hcl 0.4 mg and solifenacin 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Nov 2021to Aug 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to give informed consent and reply to questionnaires.
- Age ≥ 45 years
- IPSS ≥ 8
- OABSS ≥ 5, urgency subscore ≥2
Who cannot join
- Untreated urinary tract infection (UTI).
- Postvoid residual (PVR) more than 150 mL
- Neurogenic lower urinary tract dysfunction (LUTD).
- Depression or any psychogenic disorders.
- Diabetes mellitus, hypertension or severe cardiovascular disease.
- Prior radiation therapy to the pelvic area.
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- Prostate cancer or bladder tumor.
- Past history of tuberculosis
- Allergy or contraindication to the used medications
- Urethral stricture
- Indwelling urethral catheter
- Vesical stone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Tadalafil and Solifenacin Versus Tamsulosin and Solifenacin Combination Therapy for the Treatment of Benign Prostatic Hyperplasia With Overactive Bladder: A Randomized Controlled Trial
The investigators will compare the efficacy and safety of tadalafil/solifenacin combination therapy versus tamsulosin/solifenacin combination therapy for the treatment of BPH/OAB in a randomized controlled trial (RCT).
Read the detailed description
Benign prostatic hyperplasia (BPH) is one of the most commonly diagnosed diseases in aging men worldwide. It is commonly associated with bothersome lower urinary tract symptoms (LUTS) including voiding symptoms such as decreased force of stream, intermittent stream, hesitancy and sensation of incomplete bladder emptying and storage symptoms such as frequent urination, urgency and nocturia. LUTS especially storage symptoms interfere with the daily activities and adversely affect the quality of life (QoL).
Alpha-1 adrenergic receptor blockers have been used as a first-line treatment of LUTS suggestive of BPH (LUTS/BPH). Phosphodiesterase 5 inhibitors (tadalafil) have recently been used as initial treatment of LUTS/BPH. It was confirmed that once daily use of tadalafil 5 mg as a monotherapy is safe and has similar efficacy when compared to tamsulosin.
Combination therapy could be used in patients who have BPH with overactive bladder (BPH/OAB) and still have persistent storage symptoms despite α1- adrenergic blockers. Anticholinergics in combination with α1- adrenergic blockers have been reported to be effective in those patients. Moreover, it has been reported that tadalafil has similar efficacy and safety to solifenacin when used in combination with tamsulosin for patients with persistent storage symptoms refractory to α1- adrenergic blockers. In another study, tadalafil/mirabegron combination therapy was used for BPH/OAB and its effect appeared to be greater than the effect of tadalafil monotherapy. Also, the combination therapy of tadalafil and solifenacin was approved to achieve higher response than tadalafil monotherapy in improvement of persistent storage symptoms associated with BPH.
It was established that tadalafil can be used as a monotherapy to relieve both voiding and storage LUTS and it can be used in combination with tamsulosin or mirabegron to treat BPH/OAB. However, there is limited evidence regarding the efficacy and safety of the combined use of tadalafil and solifenacin for the treatment of BPH/OAB. Therefore, in this study, the investigators will compare the efficacy and safety of tadalafil/solifenacin combination therapy versus tamsulosin/solifenacin combination therapy for the treatment of BPH/OAB in a randomized controlled trial (RCT).
- Conditions
- Benign Prostatic Hyperplasia, Overactive Bladder
- Being tested
- Tadalafil 5mg, Tamsulosin Hcl 0.4 mg, solifenacin 10 mg
- Keywords
- Benign Prostatic Hyperplasia, Overactive Bladder, tadalafil, combination therapy for BPH
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tadalafil 5mgDrug
Also called rectalis 5 mg
patients with BPH/OAB will be treated with combination therapy of tadalafil plus solifenacin for 12 weeks in group 1
Tamsulosin Hcl 0.4 mgDrug
Also called tamsulosin 0.4 mg
patients with BPH/OAB will be treated with combination therapy of tamsulosin plus solifenacin for 12 weeks in group 2
solifenacin 10 mgDrug
patients with BPH/OAB will be treated with combination therapy of tadalafil plus solifenacin in group 1 and tamsulosin plus solifenacin in group 2 for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tadalafil / solifenacin combination therapy | Active comparator | Patients will be treated by combination of Tadalafil 5 mg + solifenacin 10 mg once daily for 12 weeks Receives: Drug: Tadalafil 5mg; Drug: solifenacin 10 mg |
| Tamsulosin / solifenacin combination therapy | Active comparator | Patients will be treated by combination of Tamsulosin 0.4 mg + solifenacin 10 mg once daily for 12 weeks Receives: Drug: Tamsulosin Hcl 0.4 mg; Drug: solifenacin 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in international prostate symptom score (IPSS) from baseline
Change in IPSS from baseline will be compared. The change of -3 will be estimated as the minimal threshold for a meaningful change. The score has a range from 0 to 35 and higher scores means a worse outcome.
Measured: 3 months
Change in overactive bladder symptom score (OABSS) from baseline
Change in OABSS from baseline will be compared. The change of -3 will be estimated as the minimal threshold for a meaningful change. The score has a range from 0 to 15 and higher scores means a worse outcome.
Measured: 3 months
Change in IPSS-quality of life (QoL) score from baseline
Change in IPSS-QoL score from baseline will be compared. It is a single question with a score ranges from 0 to 6 and higher scores means a worse outcome.
Measured: 3 months
Change in ultrasound measurement of post-void residual urine (PVR) from baseline
Change in PVR from baseline will be compared.
Measured: 3 months
Change in maximum flow rate (Qmax) from baseline
Change in Qmax from baseline will be compared.
Measured: 3 months
Adverse effects
Appearance of adverse effects related to the used medications will be reported.
Measured: 3 months
Secondary outcomes (2)
change in international index of erectile function-15 (IIEF-15)
change in IIEF-15 in sexually active patients will be compared.
Measured: 3 months
change in ejaculatory domain of male sexual health questionnaire (Ej-MSHQ)
change in Ej-MSHQ in sexually active patients will be compared.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start8 Nov 2021
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hegazy, Mansoura University
- Investigators
- Mohammed Hegazy, Principal investigator, Mansoura UniversityAhmed Elhefnawy, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494567
- Sponsor's protocol ID
- Tadalafil for BPH/OAB
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tadalafil and Solifenacin Versus Tamsulosin and Solifenacin Combination Therapy for the Treatment of Benign Prostatic Hyperplasia With Overactive Bladder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05494567
- Acronym / sponsor ID
- Tadalafil for BPH/OAB
- Conditions
- Benign Prostatic Hyperplasia, Overactive Bladder
- Keywords
- Benign Prostatic Hyperplasia, Overactive Bladder, tadalafil, combination therapy for BPH
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 10 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will compare the efficacy and safety of tadalafil/solifenacin combination therapy versus tamsulosin/solifenacin combination therapy for the treatment of BPH/OAB in a randomized controlled trial (RCT).
Detailed description
Benign prostatic hyperplasia (BPH) is one of the most commonly diagnosed diseases in aging men worldwide. It is commonly associated with bothersome lower urinary tract symptoms (LUTS) including voiding symptoms such as decreased force of stream, intermittent stream, hesitancy and sensation of incomplete bladder emptying and storage symptoms such as frequent urination, urgency and nocturia. LUTS especially storage symptoms interfere with the daily activities and adversely affect the quality of life (QoL).
Alpha-1 adrenergic receptor blockers have been used as a first-line treatment of LUTS suggestive of BPH (LUTS/BPH). Phosphodiesterase 5 inhibitors (tadalafil) have recently been used as initial treatment of LUTS/BPH. It was confirmed that once daily use of tadalafil 5 mg as a monotherapy is safe and has similar efficacy when compared to tamsulosin.
Combination therapy could be used in patients who have BPH with overactive bladder (BPH/OAB) and still have persistent storage symptoms despite α1- adrenergic blockers. Anticholinergics in combination with α1- adrenergic blockers have been reported to be effective in those patients. Moreover, it has been reported that tadalafil has similar efficacy and safety to solifenacin when used in combination with tamsulosin for patients with persistent storage symptoms refractory to α1- adrenergic blockers. In another study, tadalafil/mirabegron combination therapy was used for BPH/OAB and its effect appeared to be greater than the effect of tadalafil monotherapy. Also, the combination therapy of tadalafil and solifenacin was approved to achieve higher response than tadalafil monotherapy in improvement of persistent storage symptoms associated with BPH.
It was established that tadalafil can be used as a monotherapy to relieve both voiding and storage LUTS and it can be used in combination with tamsulosin or mirabegron to treat BPH/OAB. However, there is limited evidence regarding the efficacy and safety of the combined use of tadalafil and solifenacin for the treatment of BPH/OAB. Therefore, in this study, the investigators will compare the efficacy and safety of tadalafil/solifenacin combination therapy versus tamsulosin/solifenacin combination therapy for the treatment of BPH/OAB in a randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tadalafil / solifenacin combination therapy | Active comparator | Drug: Tadalafil 5mg, Drug: solifenacin 10 mgPatients will be treated by combination of Tadalafil 5 mg + solifenacin 10 mg once daily for 12 weeks |
| Tamsulosin / solifenacin combination therapy | Active comparator | Drug: Tamsulosin Hcl 0.4 mg, Drug: solifenacin 10 mgPatients will be treated by combination of Tamsulosin 0.4 mg + solifenacin 10 mg once daily for 12 weeks |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to give informed consent and reply to questionnaires.
- Age ≥ 45 years
- IPSS ≥ 8
- OABSS ≥ 5, urgency subscore ≥2
Key exclusion criteria (12 listed)
- Untreated urinary tract infection (UTI).
- Postvoid residual (PVR) more than 150 mL
- Neurogenic lower urinary tract dysfunction (LUTD).
- Depression or any psychogenic disorders.
- Diabetes mellitus, hypertension or severe cardiovascular disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tadalafil 5mgAlso: rectalis 5 mgpatients with BPH/OAB will be treated with combination therapy of tadalafil plus solifenacin for 12 weeks in group 1 | Drug | Tadalafil / solifenacin combination therapy |
| Tamsulosin Hcl 0.4 mgAlso: tamsulosin 0.4 mgpatients with BPH/OAB will be treated with combination therapy of tamsulosin plus solifenacin for 12 weeks in group 2 | Drug | Tamsulosin / solifenacin combination therapy |
| solifenacin 10 mgpatients with BPH/OAB will be treated with combination therapy of tadalafil plus solifenacin in group 1 and tamsulosin plus solifenacin in group 2 for 12 weeks | Drug | Tadalafil / solifenacin combination therapy, Tamsulosin / solifenacin combination therapy |
Primary outcome
Change in international prostate symptom score (IPSS) from baseline
Time frame: 3 months
Change in IPSS from baseline will be compared. The change of -3 will be estimated as the minimal threshold for a meaningful change. The score has a range from 0 to 35 and higher scores means a worse outcome.
Change in overactive bladder symptom score (OABSS) from baseline
Time frame: 3 months
Change in OABSS from baseline will be compared. The change of -3 will be estimated as the minimal threshold for a meaningful change. The score has a range from 0 to 15 and higher scores means a worse outcome.
Change in IPSS-quality of life (QoL) score from baseline
Time frame: 3 months
Change in IPSS-QoL score from baseline will be compared. It is a single question with a score ranges from 0 to 6 and higher scores means a worse outcome.
Change in ultrasound measurement of post-void residual urine (PVR) from baseline
Time frame: 3 months
Change in PVR from baseline will be compared.
Change in maximum flow rate (Qmax) from baseline
Time frame: 3 months
Change in Qmax from baseline will be compared.
Adverse effects
Time frame: 3 months
Appearance of adverse effects related to the used medications will be reported.
2 secondary outcomes
change in international index of erectile function-15 (IIEF-15)
Time frame: 3 months
change in ejaculatory domain of male sexual health questionnaire (Ej-MSHQ)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed Hegazy principal investigator
Mansoura University
Ahmed Elhefnawy study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tadalafil 5mg, Tamsulosin Hcl 0.4 mg and solifenacin 10 mg in people with Benign Prostatic Hyperplasia and Overactive Bladder, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in international prostate symptom score (IPSS) from baseline (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2022.